Diagnostic swabs



Fi led Oct. 19, 1964 INVENTORS Fnup 5.54m awl G ILE VFaZzMS BY www- ATTORNEY United States Patent C) 3,368,549 DIAGNOSTIC SWABS Fred S. Barr, Bristol, Va., and Galen F. Collins, Bristol, Tenn., assignors to The S. E. Massengill Company, Bristol, Tenn.

Filed Oct. 19, 1964, Ser. No. 404,852 7 Claims. (Cl. 128-2) The present invention relates to diagnostic swa-bs, and more particularly to swabs or swab-like structures which permit the direct contacting thereof with an area of a patients body (animal or human) suspected of possibly harboring a pathogenic micro-organism and direct culturing of the same for determination of whether or not the micro-organism was, indeed, present. More particularly, the present invention relates to such arrangement which permits the physician the possibility of avoiding the step of transferring the smear to a tube or plate containing a culture medium, While nevertheless providing the possibility of culturing the smear and thereby determining whether or not the suspected micro-organism was present in the host animal or human.

The procedure wherein a physician will contact an area of suspected infectation by a micro-organism, for example the throat or vagina of a patient, with a swab (the socalled taking of a smear) and then transferring the same to a separate prepared tube (slant) or plate of cultured media for the growing of the micro-organism, where-after the tube or plate is generally incubated, so that the physician can subsequently determine whether or not a pathogenic micro-organism was present, is well known.

It is a primary object of the present invention to provide a device and assembly which greatly facilitates this prooedure on the part of the physician by eliminating any need for transfer of the smear.

It is another object of the present invention to provide a device which permits the direct contact by the doctor of the area of the patient suspected of harboring the micro-organism with a culture medium, so that the contacted culture medium can be directly incubated for determination as to what, if any, pathogenic micro-organism might be present.

It is yet another object of the present invention to provide special culture media which permits the solidification of the same into a form so that the culture medium can be directly contacted with the area of the patient sus pected of harboring the micro-organism and subsequently incubated for determination of what, if any, micro-organism was present.

It is still a further object of the present invention to provide special culture media which, in addition to being adapted for formation into swab ends and the like, also inhibit the growth of micro-organisms other than a specific micro-organism, so that the growth of a micro-organism in such culture media is a direct indication of the presence of such specific micro-organism.

Other objects and advantages of the present invention will be apparent from a further reading of the specification and of the appended claims.

With the above and other objects in view, the present invention mainly comprises a testing assembly for determination of the presence or absence or a micro-organism in an area of a host animal or human patient, said testing assembly comprising a sterile container, and culture medium carrying means removeably housed in the interior of the container so that the culture medium carrying means can be removed from the container to be placed in contact with the area of suspected infestation of a micro-organism and then replaced in the container for incubation.

The present invention further relates to a device for 3,368,549 Patented Feb. 13, 1968 making smears of a patients area of suspected infestation of a micro-organism and determining whether or not the micro-organism is present, said device comprising an elongated support, and culture medium carrying means carried by the support at an end portion thereof to be placed in contact with the area of suspected infestation so that thereafter the same can be incubated with the means without requiring transfer to a separate culture medium or container containing a separate culture medium.

The invention is illustrated by way of example in the accompanying drawings which form part of the application and in which:

FIG. '1 illustrates a container and cap for holding the swab device in sterile condition;

FIG. 2 illustrates a swab in accordance with one embodiment of the invention; and

FIG. 2a illustrates another embodiment of a swab in accordance with the present invention.

Referring more particularly to the drawings, FIG. 1 shows a tube 10 provided with threads 11 so that a cap 12 can be securely closed onthe tube. This permits the tube to be sterilized and the contents of the tube to be maintained under aseptic conditions. In FIG. 2 an elongated handle or stick 13, which may be, for example, of wood or plastic, is provided with a mound or batting of absorbent cotton or the like 14 onto which is moulded the culture medium 15. This swab assembly is then sterilized and kept in the tube 10, which is also sterilized, with the cap 12 thereon until it is ready for use. When ready for use, the cap 12 is removed, the swab taken from the tube and the culture medium end placed in contact with the area of the patient suspected of carrying the pathogenic microorganism, for example the throat, ear, nose, vagina, or the like, and the swab is then reinserted into the tube and incubated, for example at a temperature of 25 C. to 37 C. The presence of the micro-organism is determined after the incubation period.

In FIG. 2a, an elongated handle 16, which is preferably in this case made of plastic, is provided with a lateral projection 17. The lateral projection as shown in FIG. 2a provides for a T-shaped assembly. However, the lateral projection can also be in the form of an arrowhead or any other convenient shape. This lateral projection permits the culture medium 18 to be directly moulded onto the end of the handle 16 and prevents slipping off of the moulded solidified culture medium therefrom. The resulting swab can be used in exactly the same manner as the swab of FIG. 2 for determination of the presence or absence of a micro organism in the area at which the smear is made. The smear is made by rubbing the swab directly on the surface of the tissue to be tested.

In accordance with a further embodiment of the present invention, changes are made in the normal culture medium for two purpses: (1) To-provide greater solidity which permits moulding of the cultured medium onto the stick or the like, and (2) the provision in the culture medium of an indicator which provides a characteristic color in the presence of the suspected pathogenic micro-organism, plus an antibiotic which will inhibit the growth of bacteria other than bacteria which will give the characteristic color with the indicator.

These special provisions in the cuture media of the pres ent invention will befurther explained below.

Normal culture media contain as solidifying agent up to about 2% of agar. In accordance with thepresent invention, however, it is preferred to provide about 3% of agar in the culture media inorderto provide greater solidity and to make it possibleto mould the media onto the applicator and to. prevent excessive breakage in handling and exposure to the culture..'Somewhat-morethan 3% of agar may be provided. However, it has been found that best results are obtained by the use of approximately 3% of agar in the culture media.

In connection with the other provision, (2) above, it is known, for example, that a growth of Candida albicans will give a characteristic dark brown or black color in the presence of a bismuth indicator. In accordance with the present invention, it is preferred to include neomycin in the culture media in order to inhibit bacterial growth but to permit the growth of the Candida albicans mold. Consequently, if the characteristic dark brown or black color occurs upon incubation of the applicator after contact of the swab with the tissue to be tested, this constitutes a positive identification of the presence of Candida albicans. It should be noted that the neomycin while it will inhibit bacterial growth will not inhibit the growth of other molds, such as peni-cillum, but such other mold would not give the characteristic color indicating the presence of Candida albicans.

The following examples are given to further illustrate the present invention. The scope of the invention is not, however, meant to be limited to the specific details of the examples.

Example 1 The following constitutes a diagnostic medium in accordance with the present invention for determining the presence of Candida albicans in vaginal infection. This basic medium is made antibacterial by the addition thereto of neomycin sulfate.

A medium is made of the following composition:

Percent Yeast extract 0.1 Glycine 1.0 Dextrose 1.0 Bismuth sulfite indicator 0.8 Neomycin sulfate 0.0002 Agar 3.9

Water, q.s. 100.0%.

The above composition is moulded onto a wooden stick having a cotton tip at an end thereof. The resulting swab is then placed in a sterile tube, and when ready to make the culture, it is removed and the smear made by rubbing the swab directly on the surface of the tissue to be tested. The swab is then reinserted into the tube and incubated at 25 C. to 37 C. When C. albicans is present black colonies appear, while any other fungus will not give this type of growth. Bacteria are inhibited by both the neomycin sulfate and bismuth sulfite indicator.

This replaces the present method of swabbing with a cotton-tip swab or metal speculum which is then streaked on an agar surface in a tube or plate.

Example 2 For identifying alpha and beta hemolytic streptococci and staphylococci:

Beef heart infusion 500 Tryptose 10 Sodium chloride Agar 30 Water, q.s. 1000 ml.

Example 3 For detecting bacterial growth in urine:

EMB agar- Gm. Peptone Lactos 5 Sucrose 5 Dipotassium phosphate 2 Agar -1 30 Eosin Y 0 Methylene blue .065

Water, q.s. 1000 ml.

4 This shows a green metallic sheen with E. colz'.

Example 4 For identifying staphylococci:

media- Gm. Yeast extract 2.5

Tr'yptose l0 Gelatin 3O Lactose 2 d-Mannitol 10 Sodium chloride 75 Dipotassium phosphate 5 Agar 30 Water, q.s. 1000 ml.

Example 5 For identifying Proteus:

Urea agar base Gm. Peptone 1 Dextrose 1 Sodium chloride 5 Monopotassium phosphate 2 Urea 20 Phenol red .012

Agar 30 Water, q.s. 1000 ml.

conditions and by the use of aseptic technique into the previously sterilized glass or plastic tube of FIG. 1. Representative samples of the media are checked for sterility to determine that there is no contamination during manufacturing process.

Without further analysis, the foregoing will so fully reveal the gist of the present invention that others can, by applying their present knowledge, make modifications of the invention as described herein and as set forth in the claims below without, however, departing from the spirit and scope of the invention and, consequently, such modifications are intended to be and are covered by the scope of the appended claims.

What is claimed as new and desired to be secured by Letters Patent is:

1. An arrangement for making a culture of microorganisms from animal or human tissue by direct contact of the tissue with a culture medium, said arrangement comprising an elongated support contacting and carrying substantially only a mass of sterile solidified culture medium at an end of the support, and a sterile container removably housing said support carrying said mass of sterile solidified culture medium.

2. Arrangement according to claim 1 wherein said elongated support is provided with a lateral projection at an end thereof and said sterile solidified culture medium is carried at said end over said lateral projection.

3. Arrangement according to claim 2 wherein said elongated support is made of plastic.

4. Arrangement according to claim 1 wherein said elongated support is made of plastic.

5. Arrangement according to claim 1 wherein said elongated support is made of plastic and is provided at one end with a T-shaped projection and said sterile solidified culture medium is carried at said end on said T-shaped projection.

6. Arrangement according to claim 1 wherein said elongated support is made of plastic and is provided at one end with an arrowhead-shaped projection and said sterile solidified culture medium is carried at said end on said arrowhead-shaped projection.

7. Arrangement according to claim 1 wherein said solidified culture medium is formed of at least 3% by weight of agar.

References Cited UNITED Boxell 195-100 Slobotka 195100 Melges 1282 Wegner 128-2 Bloch et a1. 128-269 Cohen 1282 Nelson 195-440 RICHARD A. GAUDET, Primary Examiner.

SIMON BRODER, Examiner. 

1. AN ARRANGEMENT FOR MAKING A CULTURE OF MICROORGANISMS FROM ANIMAL OR HUMAN TISSUE BY DIRECT CONTACT OF THE TISSUE WITH A CULTURE MEDIUM, SAID ARRANGEMENT COMPRISING AN ELONGATED SUPPORT CONTACTING AND CARRYING SUBSTANTIALLY ONLY A MASS OF STERILE SOLIDIFIED CULTURE MEDIUM AT AN END OF THE SUPPORT, AND A STERILE CONTAINER 